NCT00565097已完成2 期
Long-Acting Lanreotide as a Volume Reducing Treatment of Polycystic Livers
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Reduction of total liver volume as determined by CT scan
研究概览
简要总结
To assess the efficacy of lanreotide in controling total liver volume in patients with polycystic livers this study will be performed. A minimum of 38 patients will be recruited and randomized (1:1) to receive either verum or placebo. Lanreotide is already used in other disease states and found to be safe and non-toxic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 88 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 yrs-of age
- •Multiple cysts > 20
- •Cooperating patient
- •Is willing and able to comply with the study drug regimen and all other study requirements
- •Willingness to give written informed consent
排除标准
- •Use of oral anticonceptives or estrogen suppletion
- •Females who are pregnant or breast-feeding
- •History or other evidence of chronic pulmonary disease associated with functional limitation
- •History of severe cardiac disease
- •History or other evidence of severe illness or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
- •Symptomatic gallstones
- •Renal failure requiring hemodialysis
研究组 & 干预措施
2
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
1
Experimental
Lanreotide
干预措施: Lanreotide (Drug)
结局指标
主要结局
Reduction of total liver volume as determined by CT scan
时间窗: 6 months
次要结局
- Reduction of liver volume and individual cyst volume on CT scan.(6 months)
- Change of kidney volume and individual cyst volume on CT scan(6 months)
- Symptom evaluation by (validated) questionnaires(6 months)
研究者
研究点 (2)
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